Kornimate/medical-research-clean huggingface dataset:
metabolic changes in healthy subjects with acute binge drink

Conditions: Binge Drinking; Liver Injury; Hepatic Steatosis

Summary: the goal of this double-blinded, randomized trial is to investigate the effects of acute binge drinking on liver function, liver fat content, and lipid metabolism in healthy young subjects. the main questions it aims to answer are: 1. if acute binge drinking could alleviate liver injury and hepatic steatosis.

the goal of this double-blinded, randomized trial is to investigate the effects of acute binge drinking on liver function, liver fat content, and lipid metabolism in healthy young subjects. the main questions it aims to answer are: 1. if acute binge drinking could alleviate liver injury and hepatic steatosis. participants will be randomized into two groups (n=40) and provided vodka (1 g/kg body weight) or an equal amount of non-alcoholic beverages with the same taste and colour but without alcohol, respectively. 15 minutes later, they are successively provided with the same breakfast. venous blood samples were collected at 0h, 1h, 3h, 5h, 6h, 12h, and 24h from each subject, respectively.

Eligibility criteria:
inclusion criteria: 1. male aged 18-30 years; 2. body mass index (bmi) ranging from 18.5 to 28 kg/m²; 3. having prior experience with binge drinking or hangovers, as assessed using the personal assessment of maximum drinking capacity survey questionnaire exclusion criteria 1. with alcohol intolerance or alcohol dependence; 2. with serious health conditions, such as liver, kidney, cardiovascular, or gastrointestinal diseases; 3. vegetarians; 4. smokers; 5. with a history of drug use, including antihistamines, antihypertensives, antidiabetics, anxiolytics, and central nervous system depressants; 6. who had used antibiotics within two weeks prior to the trial; 7. who had consumed alcohol, alcoholic beverages or alcohol-containing foods within one week before the trial.

Keywords: acute alcohol intake liver
impact of anti-tnf, vedolizumab and tofacitinib on aortic stiffness, carotid intima-media thickness and cardiovascular risk of patients with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: an increased risk of cardiovascular (cv) diseases has been observed in patients with inflammatory bowel diseases (ibd). the impact of ibd drugs, such as anti-tnf, anti-integrins or anti-jak, on the risk of cv events in ibd is remains unknown. aortic pulse wave velocity (apwv), a measure of aortic stiffness, and carotid intima media thickness (cimt) are both predictors of cardiovascular events and are increased in patients with ibd. the investigators aimed to prospectively compare the cv risk, cimt, arterial stiffness and biomarkers of endothelial dysfunction at baseline and after 3 and 12 months of anti-tnf, vedolizumab and tofacitinib.


Eligibility criteria:
inclusion criteria: * ulcerative colitis evolving for at least 6 months, * patient older than 18 years, * initiating a treatment by infliximab, adalimumab, golimumab, vedolizumab or tofacitinib, * written informed consent. exclusion criteria: * patients with anti-hypertensive, antiplatelet or lipid-lowering drugs without stable dosage within the 3 months before the study and over the study period, * patients with a cardiovascular event such as myocardial infarction and stroke, * diabetic patient, * pregnant women, * minor * people unable to give their consent to participate

Keywords: ulcerative colitis cardiovascular risk cimt
post-resuscitation care registry for survival from out-of-hospital cardiac arrest

Conditions: Out-Of-Hospital Cardiac Arrest

Summary: the aim of this study is to construct multi-center post-cardiac arrest care registry that can be used for data warehousing and clinical research.

this registry prospectively enrolls adults patients survived out-of-hospital cardiac arrest in 3 academic hospital emergency departments. registered data can be used for quality control and clinical research to reduce post-cardiac arrest syndrome-related mortality.

Eligibility criteria:
inclusion criteria: * patients aged 20 years old or older who presents to the ed of the participating hospitals with any of the following criteria: 1. sustained rosc from ohca at pre-hospital level 2. sustained rosc from ohca at the ed of the participating hospitals after acls 3. patients sustained rosc from ohca and transferred from other hospital to the ed of the participating hospitals for post-cardiac arrest care exclusion criteria: * age less than 20 years old * patients with advanced directives not to deliver aggressive organ supportive management
a multicenter observational study to evaluate the effectiveness of patisiran in patients with polyneuropathy of attrv amyloidosis with a v122i or t60a mutation

Conditions: Hereditary Transthyretin-mediated (ATTRv) Amyloidosis; Polyneuropathy

Summary: to evaluate the effectiveness of patisiran in patients with attrv amyloidosis with polyneuropathy who have a v122i or t60a mutation.


Eligibility criteria:
inclusion criteria: * diagnosed with attrv amyloidosis with polyneuropathy, with a documented v122i or t60a mutation * pnd score of i-iiib at baseline. * exposure to commercial patisiran in one of the 3 cohorts: * prospective cohort: naive to patisiran treatment at the time of enrollment with intention to initiate treatment with patisiran. * mixed cohort: currently on commercial patisiran therapy for less than 12 months at study enrollment. * retrospective cohort: exposed to commercial patisiran treatment for at least 12 months prior to study enrollment, regardless of current treatment status at enrollment. exclusion criteria: * new york heart association (nyha) heart failure classification ≥3 * karnofsky performance status (kps) \<60% * unstable congestive heart failure (chf) * known primary amyloidosis (al) or leptomeningeal amyloidosis * prior major organ transplant * previously received patisiran * previous treatment with a ttr silencing therapy

Keywords: valine to isoleucine substitution at position 122 v122i threonine to alanine substitution at position 60 t60a familial amyloid polyneuropathies attr transthyretin amyloidosis transthyretin amyloidosis ttr-mediated amyloidosis rnai therapeutic fap polyneuropathies amyloid neuropathies amyloid neuropathies, familial amyloidosis, familial peripheral nervous system diseases nervous system diseases ttr neuromuscular diseases proteostasis deficiencies metabolic diseases heredodegenerative disorders, nervous system neurodegenerative diseases genetic diseases, inborn metabolism, inborn errors attrv
the retrain your brain for healthy eating study

Conditions: Obesity

Summary: the aim of this mixed methods, single-group, single-center study will be to examine the feasibility of a food response training (frt). this study will be conducted in patients with obesity recruited from nyu langone health. measurements will occur at screening, baseline, and 3 months, for a subgroup of participants for we will collect saliva samples for genetic analysis at baseline assessment (ancillary study).


Eligibility criteria:
inclusion criteria: 1. ≥18 to 80 years of age 2. bmi ≥30.0 kg/m2 3. access to a computer or an iphone/ipad or be willing to use a study loaner smart phone exclusion criteria: 1. pregnant or breastfeeding or plan to become pregnant in the next 6 months, or who become pregnant during the study 2. taking any medication that may impact dietary intake and weight: a. immunosuppressants, steroids, medications for weight loss or to manage blood sugars or a psychiatric condition other than anxiety/depression 3. enrolled in another intervention that could influence dietary intake 4. have had bariatric surgery within the past 2 years 5. unwilling to delay bariatric surgery for the next 6 months 6. who have gained or loss more than 5.5 kg in the previous 3 months 7. unable to participate meaningfully in an intervention that involves using software available in english. the reason for this is that the food training apps have not been designed or validated in audio form or in other languages. (e.g., due to uncorrected sight impairment, illiterate, non-english-speaking, dementia) 8. institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over diet), unwilling or inability to provide informed consent.

Keywords: food response training (frt)
perceptions of mdma-assisted therapy among veterans with ptsd

Conditions: Post Traumatic Stress Disorder

Summary: the goal of this exploratory, mixed-method design study is to gather qualitative and quantitative data obtained through interviews and questionnaires with veterans who are currently enrolled at the va for healthcare. the main question this study aims to answer is: how do veterans diagnosed with ptsd and enrolled for care at the va understand mdma-assisted therapy for ptsd? using a story-completion approach, participants will be provided with a brief story starter involving a fictitious character and scenario and asking them to complete the story. few contextual details will be offered about the character. in responding to ambiguous cues, participants are thought to project their conscious and subconscious perceptions about the phenomenon in question onto the story, a useful method for exploring stigmatized topics. the purpose of this exercise is to ascertain the participants attitudes and perceptions regarding mdma-assisted therapy.

veterans will be informed of the study by their va providers (behavioral health clinic, pcmhi, ptsd clinic, cdrp, primary care). veterans who are interested will have their contact information passed on to the study investigators. once screened and enrolled in the study veterans will complete a brief demographics form, and three brief symptom screening questionnaires: ptsd checklist for dsm-5, 5-item screener for ptsd, and patient health questionnaire 9. participants then engage in the recorded interview during which they are provided with a brief story starter, as described above. in the story, a fictitious veteran with a diagnosis of ptsd is offered an opportunity to enroll in a clinical trial and receive mdma-assisted therapy. participants are asked to share what questions, concerns, hopes, and expectations may be present for the fictitious veteran in the story. interviews will then be transcribed and the pi and the collaborators will read all transcriptions and generate recurring themes that can be reliably coded. the investigators will then code the transcripts for the presence of themes. data analytic plans include calculating the prevalence of each theme and examining their correlates with measures of severity of symptoms as well as any demographic variables. it is hoped that this data can inform educational and other roll-out efforts within the va system as mdma-assisted therapy approaches fda approval as a treatment for ptsd.

Eligibility criteria:
inclusion criteria: * veterans enrolled in va care * active diagnosis of ptsd, as determined by the referring provider or confirmed by medical records. * age 18 or older * fluent in written and spoken english exclusion criteria: * cognitively impaired to the extent that patient cannot comprehend the survey * has already completed the interview

Keywords: mdma mdma-assisted therapy psychedelic ptsd
a study to evaluate the safety, tolerability, pk, pd, and clinical activity of eq001 in subjects with agvhd

Conditions: Acute-graft-versus-host Disease; aGVHD; GVHD; GVHD, Acute

Summary: this is a multi-center study to evaluate the safety, tolerability, pk, pd, and clinical activity of eq001 in subjects with acute graft versus host disease (agvhd).

the study will enroll approximately 100 subjects in two (2) parts: part a is an open label study and will enroll approximately 40 evaluable subjects with agvhd across 4 cohorts. the total number of patients will depend on the number of dose escalations necessary to enable a decision to be made on the recommended dose to take forward into part b of the study. the planned dose escalation will start with cohort 1, where subjects will receive eq001 administered intravenously every two weeks for a total of 5 doses. part b is a randomized, double-blind, placebo-controlled study and will enroll approximately 60 additional subjects, randomized in a 2:1 ratio to either active treatment eq001 (40) or placebo (20). subjects will receive either eq001 or placebo administered intravenously every two weeks for a total of 5 doses.

Eligibility criteria:
inclusion criteria: 1. male or female subject at least 18 years of age for part a, and at least 12 years of age for part b. 2. recipients of allogeneic hematopoietic stem cell transplantation (allohsct) using myeloablative or non myeloablative conditioning regimens. 3. have a clinical diagnosis of acute gvhd requiring systemic immune suppressive therapy. 4. deemed by the investigator to be likely to comply with the planned procedure as required by the protocol for the duration of the study exclusion criteria: 1. presence of morphologic relapsed primary malignancy, treatment for relapse after allohsct was performed, or requirement for rapid immunosuppressive treatment withdrawal for early malignancy relapse. 2. evidence of graft failure based on cytopenia(s), and as determined by the investigator. 3. evidence of post-transplant lymphoproliferative disease. 4. any prior therapy for acute gvhd, except for allohsct prophylaxis regimens or systemically administered corticosteroids. 5. as determined by the investigator, any medical, psychiatric, or other condition or circumstance that is likely to negatively affect: the subject's participation in this clinical study, the subject's safety, or the reliability of the study data.
use of oraquick for screening hiv in children less than eighteen months old

Conditions: HIV Antibody Testing

Summary: blood is the most commonly used specimen to test for hiv. in the past 20 years, use of saliva as an alternative specimen for hiv testing has been explored. today, very sensitive tests have been formulated and have been used for diagnosing hiv in adults and older children. oraquick, a rapid test, is one such example. it is a devise that can be used to collect as well test the saliva. most studies done on the use of saliva have been carried out in adults and have produced very good results. however very few such studies have been done in children, especially infants. in adults, use of saliva has also highlighted the advantages of ease of collection and increased acceptability of testing. hypothesis oraquick rapid test can detect antihiv antibodies as well as the abbott determine test and oral fluid testing is more acceptable than blood testing.

background serological identification of antibodies to human immunodeficiency virus (hiv) in blood is the most widely used method to screen for hiv infection. use of oral fluid as an alternative to blood sample has been studies the past 20 years and extremely sensitive tests that are able to detect the very low quantities of antibodies found in oral fluid have been formulated and are currently being used. oraquick rapid test, a combination, collection and testing device that uses both blood and oral fluid was approved for used by the u.s.a, fda in 2002 and has been tested in adults and older children. the value of oral fluid in screening for hiv infection in adults is now well established and has been used extensively in field survey and epidemiologic studies. however, these methods have not been studied in children in whom differences in test performance might be expected. studies in adults have also highlighted the advantages of oral fluid testing, such as ease of collection and high degree of acceptability of testing. this would make oral fluid testing a good alternative for hiv screening in infants, a challenging population in which venipuncture is often difficult or unacceptable.

Eligibility criteria:
inclusion criteria: * children aged less than 18 months * admission to the department of pediatrics for any condition * consent from caregiver for hiv testing using both oral fluid and blood r exclusion criteria: * age of more than 18 months * refusal of consent by caregiver * outpatients

Keywords: hiv-1 hiv-2
caregiver support model & psycho-education program on empowerment: development and validation

Conditions: Caregiver Burnout; Case Management; Empowerment

Summary: this project aims to provide social workers and relevant human service professionals with a comprehensive, scientific, and validated service model and suggest a sustainable support framework on the working process of helping and empowering family caregivers of frail elders, reducing caregiving distress, and enhancing caregivers' quality of life. the proposed project consists of two parts to be conducted in 1 year. the first part focuses on the development and validation of caregiver support model (csm) with a randomized controlled trial (rct) study. the second part develops and validates a psycho-education program on empowering family caregivers with another randomized controlled design. in the first year, the project team have (1) developed and designed different components of the caregiver support model (csm), including a comprehensive need assessment tool, personalized caregiver intervention plan guidelines and template, and online database on caregiver services and community resources, (2) designed a five-session psycho-education program on empowerment. the caregiver needs assessment (cna) tool was also pilot-tested with 320 community caregivers. results from the survey, together with the systematic review on caregiver support, will form the backbone of the later cna implementation. the working model will be validated using rct design with 400 family caregivers recruited through 4 collaborating ngos. at the same time, a psycho-education program on empowerment will be developed and validated using rct design with another 190 caregivers.

participants of csm will be randomly assigned to csm intervention and non-csm intervention which is the usual practice of case handling by centre staff. randomization will be based on centres to prevent exchange of information between the two groups, and thus causing contamination. outcome data will be measured at 3 time-intervals: case intake, 3-month, and 6-month. participants of the psychoeducation program on empowerment (ppe) will be randomly assigned to the program group and the non-program group. for the former a 5-session psychoeducation program will be administered. for both groups, outcome measures will be collected at pre, post, and 3-month after post test.

Eligibility criteria:
csm inclusion criteria: * primary family caregivers aged 21 or above; * have not received major/ intensive services in the past three months; * providing care for elderly aged 60 or older; * care recipient has at least one difficulty in activities of daily living or instrumental activities of daily living that needs help from the caregiver (scored 3 or higher on at least one of the items in the adl/iadl checklist). ppe inclusion criteria: * primary family caregivers aged 21 or above; * family caregiving in stable situation or care recipient passed away within 2 years; * have not received systematic psychoeducation in the past three months.

Keywords: caregiver support intensive case management empowerment for caregivers
mode of induction in fetal growth restriction and its affects on fetal and maternal outcomes

Conditions: Fetal Growth Retardation; Induction of Labor Affected Fetus / Newborn

Summary: to compare methods of induction of labor in fetal growth restriction and its effect on maternal and neonatal outcome

intra uterine growth restriction (fgr) is a condition in which the fetus does not realize its growth potential in uterus. the excepted definitions of this condition are fetal weight estimation below the 10th percentile per gestational week. severe growth restriction is defined as estimated weight below the 3rd percentile. it is well known that fetuses which are growth restricted are subjected to a higher degree of complications during pregnancy and delivery such as fetal distress, hypoxic damage, intra uterine fetal demise and complications in the neonatal period including prolonged nicu hospitalization, cerebral palsy, hypoxic ischemic encephalopathy and also long term affects such as neuro developmental complications. common practice in managing these cases is induction of labor at term around 37 weeks of gestations to prevent these complications as it established that during this time there is a substantial rise in pregnancy complications including fetal demise. there are no clear guide lines how to induce labor in such cases and it is not known what is the safest and the most effective way to induce labor in these cases. prior studies have found the rate of successful vaginal birth in these cases vary between 50 and 80%. there are a number of methods of labor induction and delivery available including the use of vaginal prostaglandins (pge2) for cervical ripening, intracervical balloon catheter or planned cesarean. in most cases when aiming for vaginal delivery the choice is between ripening of the cervix with balloon catheter in combination with pitocin or ripening with prostaglandins. it is not known which method is safer and more successful in growth restricted fetuses.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * fetal growth restriction defined as estimated fetal weight between the 3rd and 10th percentile per gestational age and are intended to deliver vaginally * gestational age between 36 and 42 weeks * no known fetal anomalies exclusion criteria: * fetal estimated weight below the 3rd percentile * known fetal anomalies * contraindications for vaginal delivery: breech presentation, abnormal doppler flow velocimetry of fetal ductus venosus. * oligohydramnios defined as amniotic fluid index below 5 cm * contraindication to the use of prostaglandins * fetal distress requiring emergent cesarean section * all other condition preventing vaginal delivery as decided by a senior physician
comparison between roll versus magnetic seed for preoperative localization of non-palpable breast lesion by randomized clinical study.

Conditions: Breast Cancer

Summary: several localization techniques are now in use for localization of non-palpable breast lesions. several studies have compared wire guided localization (wgl), which has been for years the gold standard for non-palpable breast lesions' localization, with more modern techniques. scientific evidence supports the efficacy of the new "wire-free" techniques, which appear to be comparable to the wgl in terms of safe surgical resection, while overcoming limitations associated with logistic difficulties and patient discomfort. there is still limited data in literature on the comparative effectiveness of these modern techniques, and there is no strong evidence that one is superior to the others. in particular, no randomized trials of comparison between roll and magnetic seed localization are currently available. the aim of this randomized study is to compare roll with magnetic seed to assess their efficacy for non-palpable breast lesions' localization.


Eligibility criteria:
inclusion criteria: * female; * non-palpable breast lesions; * indication to lesion's surgical excision (lumpectomy, quadrantectomy) * preoperative diagnosis on histology or cytology of borderline lesion (b3 or c3) or malignant lesion (b4-b5 or c4-c5); * written informed consent. exclusion criteria: * benign lesion at diagnosis on preoperative core biopsy (b2) or fine needle aspiration (c2); * clinically palpable breast lesion; * breast lesion localization for planned neoadjuvant chemotherapy.

Keywords: non-palpable breast lesion